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Trial record 1 of 4 for:    S-equol | Alzheimer Disease
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S-Equol in Alzheimer's Disease 2 Trial (SEAD2)

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ClinicalTrials.gov Identifier: NCT03101085
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : August 13, 2021
Sponsor:
Collaborator:
Ausio Pharmaceuticals, LLC
Information provided by (Responsible Party):
Russell Swerdlow, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE March 29, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date August 13, 2021
Actual Study Start Date  ICMJE May 5, 2017
Actual Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2017)
Difference in cytochrome oxidase/citrate synthase (COX/CS) activity [ Time Frame: One Month ]
Measured as the mean intra-individual COX/CS activity
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
  • Safety laboratories evaluation and participant/study partner reporting of symptoms or adverse events [ Time Frame: Month 4 ]
    Measured as adverse events reported over the course of the study (safety labs, physical and neurological exams, vital signs, signs and symptoms)
  • Montreal Cognitive Assessment (MoCA) Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-30 (higher score indicates better result)
  • Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11) Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-70 (lower score indicates better result)
  • Logical Memory Test (LMT) - immediate and delayed recall Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-25 (higher score indicates better result)
  • Stroop Test Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-unlimited (higher score indicates better result)
  • Pattern of COX activity changes while on the active treatment versus placebo arms of this crossover study. [ Time Frame: Months 1, 3, 4 ]
    Pts will categorically be defined as responders or non-responders depending on the slope of COS/CS activity change.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2017)
  • Safety of S-equol [ Time Frame: Month 4 ]
    Measured as adverse events reported over the course of the study (safety labs, physical and neurological exams, vital signs, signs and symptoms)
  • Montreal Cognitive Assessment (MoCA) Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-30 (higher score indicates better result)
  • Alzheimer's Disease Assessment Scale-Cognitive Portion (ADASCog-11) Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-70 (lower score indicates better result)
  • Logical Memory Test (LMT) - immediate and delayed recall Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-25 (higher score indicates better result)
  • Stroop Test Determine if S-equol influences participant scores. [ Time Frame: Months 2, 3, 4 ]
    Scale range: 0-unlimited (higher score indicates better result)
  • Determine if S-equol produces evidence of increase platelet mitochondria (COX) activity. [ Time Frame: Months 1, 3, 4 ]
    Pts will categorically be defined as responders or non-responders depending on the slope of COS/CS activity change.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S-Equol in Alzheimer's Disease 2 Trial
Official Title  ICMJE S-Equol in Alzheimer's Disease 2 (SEAD2) Trial
Brief Summary By doing this study researchers hope to learn if S-equol, a compound that acts like estrogen in the body, causes an increase in mitochondrial activity. Researchers also hope to determine the safety and tolerability of a therapeutic dose of S-equol and whether or not it influences cognition.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: S-equol
    S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules
    Other Name: AUS-131
  • Other: Placebo
    Placebo capsules matched in size and color to S-equol capsules
Study Arms  ICMJE
  • Experimental: S-equol
    Participants will receive S-equol 50mg twice daily for one month
    Intervention: Drug: S-equol
  • Placebo Comparator: Placebo
    Participants will receive matched placebo pill to take twice daily for one month
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2021
Actual Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a diagnosis of Alzheimer's Disease (AD)
  • Have a study partner who has a close relationship with the participant and will attend study visits with the participant
  • Do not possess an Alkylphenol ethoxylates 4 (APOE4) variant of the APOE gene
  • Speak English as their primary language
  • Have not had any medication changes within the past 30 days

Exclusion Criteria:

  • Reside in a nursing home or dementia special care unit
  • Have a potentially confounding, serious medical risk such as insulin-requiring diabetes, any history of cancer that required a chemotherapy or radiation therapy intervention within the past 5 years, or a recent cardiac event
  • Have any clinically significant abnormal safety laboratory values at the SEAD2 screening visit
  • Have any clinically significant abnormal findings on vital signs measurements, or on physical or neurological examination at the SEAD2 screening visit
  • Use any type of systemic estrogen or testosterone replacement therapy
  • Has participated in another clinical trial or received any investigational drug or investigational therapy within 30 days before the screening visit
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03101085
Other Study ID Numbers  ICMJE SEAD2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Russell Swerdlow, University of Kansas Medical Center
Study Sponsor  ICMJE Russell Swerdlow
Collaborators  ICMJE Ausio Pharmaceuticals, LLC
Investigators  ICMJE
Principal Investigator: Russell Swerdlow, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP